EU – Biotech Act Public Consultation The European Commission has launched a public consultation on the Biotech Act, closing on 10 November 2025. EU – Biotech Act Public Consultation
MHRA Designated as WHO-Listed Authority MHRA has been designated as a WHO-Listed Authority (WLA) by the World Health Organization (WHO). MHRA Designated as WHO-Listed Authority
MHRA – MORE User Reference Guide Update MHRA has published an updated version of the MORE Submissions - user reference guide MHRA – MORE User Reference Guide Update
EMA Industry Standing Group June 2025 – Highlight Reports The European Medicines Agency (EMA) has published its Highlight Report from the Industry Standing Group (ISG) meeting that took place on 30 June 2025. EMA Industry Standing Group June 2025 – Highlight Reports
EU MDR – Notified Bodies Survey on Certifications & Applications up to 28 February 2025 The European Commission has published the Notified Bodies Survey on certifications and applications (EU MDR/IVDR) based on data collected from 51 notified bodies until 28 February 2025 EU MDR – Notified Bodies Survey on Certifications & Applications up to 28 February 2025
DHSC Public Appointments: April 2025 – March 2026 The Department of Health and Social Care (DHSC) has announced its non-executive appointments for the period from April 2025 to March 2026. DHSC Public Appointments: April 2025 – March 2026
Talc – CLP Category 1B Carcinogen Classification – Webinar Following the proposed harmonised classification and labelling at EU level of Talc as a category 1B carcinogen, EUROTALC is organising a webinar on 23 September 2025 16:00 to 17:30 CEST. Talc – CLP Category 1B Carcinogen Classification – Webinar
MHRA – Adverse Event Reporting in DMHTs and Development of Updates to Regulatory Guidance The MHRA has published guidance for manufacturers of digital mental health technologies (DMHTs) that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply. MHRA – Adverse Event Reporting in DMHTs and Development of Updates to Regulatory Guidance
UK REACH: Rationale for priorities 2025-2026 Defra, and the Scottish and Welsh Governments have set out a rationale for the UK REACH work programme for the 2025-2026 financial year. UK REACH: Rationale for priorities 2025-2026
MHRA Publishes Statement of Policy Intent: Early Access to Innovative Medical Devices The MHRA is setting out its intention to enable earlier access to innovative medical devices that address unmet clinical needs within the NHS. MHRA Publishes Statement of Policy Intent: Early Access to Innovative Medical Devices
EU-US Trade Deal Agreement – Tariffs Impact On 27 July 2025, the EU and US reached an agreement on a EU-US trade deal, covering import and export tariffs and other trade regulations. EU-US Trade Deal Agreement – Tariffs Impact
Government’s Response to the Consultation on Future Routes to Market for Medical Devices in Great Britain MHRA has published the government’s response to its public consultation on future routes to market for medical devices in Great Britain setting out MHRA's response to the proposals relating to international reliance, UKCA marking and the regulation of Class B in vitro diagnostic devices. Government’s Response to the Consultation on Future Routes to Market for Medical Devices in Great Britain
